Cognitive Behaviour Therapy (CBT) for Body Dysmorphic Disorder (BDD)

Not Applicable

Completed

Conditions: Body Dysmorphic Disorder

Registration Number: NCT00871143

Lead Sponsor: Institute of Psychiatry, London

Brief Summary: The aim of the research is to determine if Cognitive Behaviour Therapy (CBT) specific for BDD is more effective than a credible non-specific form of CBT for treating BDD and its delusional variant in adults aged 17 or over. This will be done in a single centre randomised controlled trial that compares specific CBT for BDD versus non-specific CBT over 12 weeks. The hypotheses to be tested are that: (1) specific CBT for BDD will be more effective than non-specific CBT at 12 weeks (2) Treatment effects from Specific CBT will be maintained at 1 month follow up. The main study end-point is at 12 weeks and the secondary end-point is at 1 month follow up. A secondary aim is to explore whether delusionality (insight) as measured by the Brown Assessment of Beliefs and co-morbid depressed mood predicts response to treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

Inclusion Criteria

BDD is the main psychological problem. We will use DSMIV criteria as BDD does not exist as a separate diagnosis in ICD10. They may have an additional diagnosis of Delusional Disorder when it refers to beliefs about being ugly or defective.
They must have a total of 24 or more on the twelve-item YBOCS modified for BDD (Phillips et al., 1997).
They may be of either gender but must be 17 years or above.
They are willing to travel to the treatment centre for weekly sessions.
They are wiling to complete regular questionnaires and be audiotaped for supervision and for listening to enhance their learning.
They may be taking psychotropic medication so long as it is stabilised and there are no plans to increase the dose.

Exclusion Criteria

They have a current or past diagnosis of schizophrenia, bipolar affective disorder.
They have current suicidal intent or severe self-neglect that requires hospitalisation.
They have a current alcohol or substance dependence or anorexia nervosa or borderline personality disorder that requires treatment in its own right.
They are currently receiving any other form of psychotherapy,
They have received CBT for BDD in the past 6 months, which is judged as competently delivered and did not respond.
They cannot speak sufficient English for CBT. (Assistance will be provided for those who speak English but are unable to read questionnaires).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)	12 weeks, 1 month post treatment	This is a clinician-rated scale administered by a trained blinded assessor. The range is 0-48. Cronbach's α for the scale is 0.80. Response to treatment is defined as a 30% or greater decrease in the total BDD-YBOCS score, which best corresponded to 'much improved' on the Clinical Global Impression (CGI) scale. In the original validation study, this cutoff score produced 1 false negative (96% sensitivity), that is, 1 participant who was rated as much or very much improved on the CGI was not classified as a responder on the BDD-YBOCS using the 30% threshold.

Secondary Outcome Measures

Name	Time	Method
Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)	12 weeks, 1 month post treatment	BABS is a 7-item clinician scale rated by a blinded assessor to measure the strength of conviction in a belief (e.g. 'I am as ugly as the Elephant man'); each item is rated from 0 ('non-delusional belief, or least pathological') to 4 ('delusional belief, or most pathological') and the total scores range from 0 to 24; higher scores represent an increasing delusionality of beliefs; respondents are classified as having delusional BDD beliefs if their total score is 18 or more, and if they score 4 on the first item, indicating they are completely convinced that their belief is accurate.
Appearance Anxiety Inventory (AAI)	12 weeks, 1 month post treatment	The AAI is a 10- item self-report questionnaire for measuring the frequency of avoidance behaviour and threat-monitoring (e.g. checking, self-focussed attention) that are characteristic of a response to a distorted body image; each item is scored from 0 ('not at all') to 4 ('all the time'), and the range of the total scores is 0-40, with higher scores reflecting a greater frequency of the responses; the AAI has a Cronbach's α of 0.86.
Body Image Quality of Life Inventory (BIQLI)	12 weeks, 1 month post treatment	The BIQLI is a 19-item self-report scale that measures the impact of body image concerns on a broad range of life domains (e.g. sense of self, social functioning, sexuality, emotional well-being, exercise and grooming); the BIQLI is scored as the average numeric score of all the items from -3 ('very negative effect') to +3 ('very positive effect'); Cronbach's α for the scale is 0.95.
Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).	12 weeks, 1 month post treatment	MADRS is a 10-item clinician scale rated by a blinded assessor to measure symptoms of depression; each item is rated on a 7-point Likert scale from 0 (indicating 'normal' or 'no difficulties') to 6, and the range is 0-60; higher scores reflect a greater symptomatology; a MADRS total score of ≥ 25 is regarded as moderate, and of \>31 as severe.
Patient Health Questionnaire (PHQ)-9	12 weeks, 1 month post treatment	The PHQ is a 9-item self-report measure of depression; each item is scored from 0 ('not at all') to 3 ('nearly every day'),and the summed total score ranges from 0 to 27, with higher scores reflecting a greater symptomatology of depression; Cronbach's α for the scale is 0.89.
Generalised Anxiety Disorder (GAD)-7	12 weeks,1 month post treatment	The GAD-7 is a 7-item self-report measure for symptoms of generalised anxiety; each item is scored from 0 to 3, and the summed total score ranges from 0 to 21, with higher scores reflecting a greater symptomatology; Cronbach's α for the measure is 0.92.